Only fed study [Design Issues]
With reference to ANDA submission for US FDA, If the prescribing information says that the drug has to be taken under fed condition then whether it is necessary to conduct both fasted and fed studies? Can we only submit the fed study for immediate release formulation?
Bioequivalence and Bioavailability Forum
| Admin contact
19,514 posts in 4,141 threads, 1,336 registered users;
online 6 (0 registered, 6 guests [including 5 identified bots]).
Forum time (Europe/Vienna): 05:01 CEST
I have not failed 700 times. I have not failed once.
I have succeeded in proving
that those 700 ways will not work.
The BIOEQUIVALENCE / BIOAVAILABILITY FORUM
is hosted by
Ing. Helmut Schütz